ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2022-00295
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- April 21, 2022
- Report Date
- November 22, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K163018 DEVICE EVALUATION THE ZILBS-635-10-8 DEVICE OF LOT NUMBER C1847759 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE(B)(6)2022. REFER TO ATTACHMENTS PR (B)(6)LAB ATTENDANCE FOR LAB ATTENDANCE AND THE RETURNED PRODUCT-NOTES FIELD FOR LAB EVALUATION NOTES. THE RETURNED DEVICE LAB EXAMINATION FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH ATTACHED PHOTOS. ON EVALUATION OF THE DEVICE THE FOLLOWING WAS OBSERVED: VISUAL INSPECTION ¿ RED SAFETY TAB NOT RETURNED FUNCTIONAL INSPECTION ¿ ¿ DEVICE FLUSHED WITHOUT ISSUE. ¿ 0.035-INCH WIRE GUIDE WAS UNABLE TO PASS THE DEVICE APPROX. 12.5CM FROM WIRE GUIDE LUMEN PORT. ¿ UNABLE TO MOVE THE CANNULA ¿ UNABLE TO DEPLOY THE STENT. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO PATIENT ANATOMY. FROM THE ADDITIONAL INFORMATION RECEIVED, IT IS KNOWN THAT THE PATIENT WAS BEING TREATED FOR A GROWTH. THIS COULD HAVE ADDED EXCESSIVE PRESSURE ON THE DEVICE WHILE IN USE, WHICH MAY HAVE CONTRIBUTED TO THE INABILITY TO DEPLOY THE STENT. IT MAY ALSO HAVE CAUSED DAMAGE TO THE INNER CARRIER AND THE CANNULA CAUSING THE INABILITY OF THE WIRE GUIDE TO BE PASSED THROUGH THE DEVICE DURING THE LAB EVALUATION. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE ON THE SAME DAY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # K163018. DEVICE EVALUATION. THE ZILBS-635-10-8 DEVICE OF LOT NUMBER C1847759 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 20TH (B)(6) 2022. ON EVALUATION OF THE DEVICE THE FOLLOWING WAS OBSERVED: VISUAL INSPECTION ¿ RED SAFETY TAB NOT RETURNED. FUNCTIONAL INSPECTION. DEVICE FLUSHED WITHOUT ISSUE. 0.035 INCH WIRE GUIDE WAS UNABLE TO PASS THE DEVICE APPROX. 12.5CM FROM WIRE GUIDE LUMEN PORT. UNABLE TO MOVE THE CANNULA. UNABLE TO DEPLOY THE STENT. DOCUMENT REVIEW. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO PATIENT ANATOMY. FROM THE ADDITIONAL INFORMATION RECEIVED, IT IS KNOWN THAT THE PATIENT WAS BEING TREATED FOR A GROWTH. THIS COULD HAVE ADDED EXCESSIVE PRESSURE ON THE DEVICE WHILE IN USE, WHICH MAY HAVE CONTRIBUTED TO THE INABILITY TO DEPLOY THE STENT. IT MAY ALSO HAVE CAUSED DAMAGE TO THE INNER CARRIER AND THE CANNULA CAUSING THE INABILITY OF THE WIRE GUIDE TO BE PASSED THROUGH THE DEVICE DURING THE LAB EVOLUTION. SUMMARY. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE ON THE SAME DAY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE BILIARY SEMD DID NOT DEPLOYED INSIDE COMMON BILE DUCT WHILE ERCP.
SUPPLEMENTAL REPORT REQUIRED DUE TO LAB EVALUATION COMPLETED ON 20TH JUNE 2022: VISUAL: RED SAFETY TAB NOT RETURNED. FUNCTIONAL: DEVICE FLUSHED WITHOUT ISSUE. 0.035 INCH WIRE GUIDE UNABLE TO PASS THE DEVICE APPROXIMATELY 21.5CM FROM WIRE GUIDE LUMEN PORT. UNABLE TO MOVE THE CANNULA AND UNABLE TO DEPLOY THE STENT.
SUPPLEMENTAL CANCELLATION REPORT REQUIRED DUE CANCELLATION OF THE REPORT DUE TO RE-ASSESSMENT.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION ON THE INVESTIGATION. NOTE: A CANCELLATION REPORT (3001845648-2022-00295 FOLLOW-UP#2) WAS PREVIOUSLY SUBMITTED FOR THIS COMPLAINT IN ERROR. THIS SHOULD HAVE BEEN A COMPLETED REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 581909 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G50624 | C1847759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |